1110O - Personalized treatment according to geriatric assessment in first-line recurrent and/or metastatic (R/M) head and neck squamous cell cancer (HNSCC) patients aged 70 or over: ELAN (ELderly heAd and Neck cancer) FIT and UNFIT trials

Abstract

BackgroundThe main challenges in patients (pts)>= 70y are to cope with the treatment benefit/risk ratio and tumor related symptoms; no standard systemic treatment has been validated. With GERICO-GORTEC groups, we developed a large prospective clinical program named ELAN to improve the management of elderly HNSCC using an adapted geriatric evaluation feasible in daily practice and to set new standards of care for these pts. We report the results of ELAN FIT and UNFIT trials dedicated to elderly R/M HNSCC pts.Table: 1110OTable: 1110OELAN-FIT trialELAN-UNFIT trial N=82Carbo-5FU-cetux (n=78)CX arm (n=41)MTX arm (n=41)Pts PS ECOG 0-1 (n=47) (2 arms together)Pts PS ECOG 2 (n=35) (2 arms together)Adverse events>=grade 424%27%22%13%40%Objective response rateAt W12: 38% (central review)12%15%13%14%OS median (months)14.7 (95%CI=11.0-18.2)4.6 (95%CI=2.4-7.3)4.6 (95%CI=2.3-7.7)7.3 (95%CI=4.6-9.6)2.1 (95%CI=1.5-3.2)1-year OS rate58% (95%CI=46%-68%)22.5% (95% CI=12.3%-37.5%)14.6% (95% CI=6.9%-28.4%)27.7% (95% CI=16.9%-41.8%)5.9% (95% CI=1.6%-19.1%)PFS median (months)7.1 (95%CI=5.5-8.2)2.4 (95%CI=1.5-3.8)2.8 (95%CI=1.6-4.2)3.8 (95%CI=2.6-5.5)1.5 (95%CI=1.2-2.3)1-year PFS rate24.5% (95%CI=15.5%-34.6%)7.5% (95% CI=2.6%-19.9%)7.3% (95% CI=2.5%-19.4%)12.8% (95% CI=6.0%-25.2%)0% MethodsTo be included in one of the 2 trials, 1st line R/M SCCHN pts>= 70y must first be enrolled in ELAN-ONCOVAL study where they were classified as fit or unfit, using the ELAN geriatric evaluation (EGE). Comprehensive Geriatric Assessment was optional. Fit pts were proposed to be enrolled in the 2-stage phase II ELAN-FIT trial, which evaluated the cetuximab-carboplatin-5FU (EXTREME) combination in terms of efficacy (objective response at 12 weeks) and safety assessed by lack of grade>=4 toxicity and lack of loss of independence. Unfit pts were proposed to be enrolled in the randomized phase III ELAN-UNFIT trial, that compared 2 monotherapies, cetuximab (Cx) 500mg/m² every 2 weeks versus weekly methotrexate (MTX) 40mg/m² in terms of failure free survival (failures are progression, treatment stop, loss>= 2 points in Activities in Daily Living scale or death). Results160 pts were enrolled in the trials. The UNFIT trial was stopped after futility analysis. Main results are shown in the table. ConclusionsFit elderly pts as selected using EGE, benefited from carboplatin based EXTREME regimen, with promising overall survival (OS), which compares favourably with that of younger pts. For unfit elderly pts, there was no efficacy difference of Cx and MTX. PS ECOG 2 pts did not benefit from systemic treatment. New therapeutic options should be explored for ECOG 0-1 unfit elderly pts. Clinical trial identificationELAN-UNFIT: NCT01884623 ELAN-FIT: NCT01864772. Legal entity responsible for the studyGustave Roussy and GORTEC. FundingINCA PAIR, Merck, Sandoz, GEMLUC-GEFLUC. DisclosureJ. Guigay: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy: Innate Pharma; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck. C. Even: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Advisory / Consultancy: Innate Pharma. L. Geoffrois: Honoraria (self), Travel / Accommodation / Expenses: BMS; Honoraria (self), Travel / Accommodation / Expenses: MSD; Honoraria (self): Ipsen; Honoraria (self): Novartis; Travel / Accommodation / Expenses: Merck Serono. C. Sire: Travel / Accommodation / Expenses: Merck. J. Fayette: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Innate; Honoraria (self), Advisory / Consultancy: Biogen. F. Peyrade: Advisory / Consultancy: MSD; Advisory / Consultancy: Merck. P. Debourdeau: Non-remunerated activity/ies: Pfizer; Honoraria (self): Leo Pharma; Honoraria (self): Bayer. Y. Pointreau: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: MSD. All other authors have declared no conflicts of interest.